TaiMed submits BLA to FDA for HIV candidate ibalizumab

TaiMed Biologics Inc. (TPEx:4147) submitted a BLA to FDA for ibalizumab (TMB-355) to treat multidrug-resistant HIV-1 infection. TaiMed partner Theratechnologies Inc. (TSX:TH) said ibalizumab does not require daily dosing and would be the first antiretroviral treatment with a new mechanism of action approved by FDA in nearly a decade.

Ibalizumab is a humanized mAb against CD4 that prevents viral entry. It has breakthrough therapy and Orphan Drug designations to treat HIV, and TaiMed has requested that it receive Priority Review...